Single-arm, Single-center, Exploratory Phase II Clinical Study of Envafolimab Combined With Chemo… (NCT06239870) | Clinical Trial Compass
UnknownPhase 2
Single-arm, Single-center, Exploratory Phase II Clinical Study of Envafolimab Combined With Chemoradiotherapy in the Treatment of Locally Advanced pMMR/MSS Rectal Cancer
China35 participantsStarted 2023-04-01
Plain-language summary
Preoperative radiotherapy combined with 5-fluorouracil/capecitabine is currently the standard treatment for locally advanced rectal cancer. Although this strategy effectively reduces the risk of local recurrence, it fails to effectively improve the overall survival rate of patients . The root cause is that 5-fluorouracil/capecitabine based local radiotherapy is not effective in controlling potential micrometastases. Therefore, many studies try to combine preoperative radiotherapy with more intense chemotherapy and targeted drugs at the same time, as well as induction chemotherapy before preoperative radiotherapy and consolidation chemotherapy after, in order to obtain better efficacy. However, a number of studies have shown that increasing cytotoxic drugs fail to effectively improve pathologic complete response rate (pCR) and long-term survival rate, and significantly increase therapeutic toxicity . Therefore, the idea of trying to increase the efficacy of cytotoxic drugs by accumulating them does not work.Based on the use of PD-1/PD-L1 antibody in colorectal cancer and other solid tumors, and referring to the scheme of PD-1/PD-L1 antibody combined with radiotherapy in other solid tumors, we added envafolimab to local radiotherapy for advanced rectal cancer for exploration, with a view to further improving the pCR rate and long-term survival of patients.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1\) Disease characteristics
* Histologically confirmed rectal adenocarcinoma; Immunohistochemical confirmation as pMMR or/and pCR or/and NGS test as MSS;
* Tumor location within 12cm from anal margin;
* Locally advanced rectal cancer (stage II-III, i.e. cT3-4 and/or N+) as assessed by the UICC/AJCC TNM staging system (8th edition, 2017);
\* Preoperative staging method: pelvic MRI/ transrectal ultrasound combined with preoperative staging.
* No signs of intestinal obstruction; Or intestinal obstruction has been relieved after proximal colostomy surgery;
* Preoperative chest, abdominal and pelvic CT to exclude distant metastasis. 2) Patient characteristics
* Age: 18 \~75 years old;
* Activity status score: ECOG 0-1;
* Life expectancy: more than 2 years;
* Hematology: WBC\>3500×106/L; PLT\>100000×106/L; Hb\>10g/dL;
* Liver function: SGOT and SGPT are less than 1.5 times of normal value; Bilirubin less than 1.5mg/dL;
* Kidney function: creatinine \<1.8mg/dL;
* Other: non-pregnant or breastfeeding women; No other malignant disease (other than non-melanoma or carcinoma in situ of the cervix) within 5 years or during the same period; Does not have a mental illness that prevents informed consent; There were no other serious diseases associated with shorter survival.
* Patients or family members can understand the study protocol and are willing to participate in the study, and sign a written informed consent;
* Good patient comp…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.